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GMP+ Feed Safety Assurance scheme
BA Product standards
GMP+ BA1 1
Version: 17 March 2010Effective from: 17 March 2010
EN
© GMP+ International B.V.
All rights reserved. The information in this publica- tion may be consulted on the screen, downloaded and printed as long as this is done for your own, non-commercial use. For other desired uses, prior written permission should be obtained from the GMP+ International B.V.
4.2.1 General 444.2.2 Questionnaire for basic products 464.2.3 Questionnaire for by-products 474.2.4 Questionaire for compound feeds 494.2.5 Fumigators 50
1 INTRODUCTION 51
2 ADDITIONAL PROVISIONS 52
2.1 GENERAL 52
2.2 COMPOUND FEED 53
INDEX
1 INTRODUCTION 4
1.1 GENERAL 4
1.2 STRUCTURE OF THE GMP+ FEED SAFETY ASSURANCE SCHEME 4
PART A: PRODUCT STANDARDS 6
1 INTRODUCTION TO THE PRODUCT STANDARDS 6
2 CONDITIONS 6
3 SUMMARY GMP+ PRODUCT STANDARDS FOR THE ANIMALFEED SECTOR 8
4 RESIDUE LEVELS OF PESTICIDES IN FEEDS 44
4.1 INTRODUCTION 44
4.2 THE ESTABLISHMENT OF AND MRL 44
4.3 SPECIAL REQUIREMENTS 50
PART B: RESIDUE STANDARDS 51
2.2.1 Installation Carry-over level: 532.2.2. The coefficient 532.2.3. Carry-over and flush batches 542.2.4 Items for attention and other remarks 54
2.3 PREMIX 552.3.1 General 552.3.2 Direct contamination 552.3.3 Indirect contamination 55
3 RESIDUE STANDARDS FOR CRITICAL ADDITIVES 56
3.1 SUMMARY OF RESIDUE STANDARDS FOR COCCIDIOSTATS AND
HISTOMONOSTATS ACCORDING TO DIRECTIVE 2002/32/EC AMENDING ANNEX I TO
DIRECTIVE 2002/32/EC 56
3.2 ADDITIONAL INFORMATION FOR SOME COCCIDIOSTATS AND
HISTOMONOSTATS * 61
Product Standards 2/71
17 March 2010 GMP+ International
4 RESIDUE STANDARDS FOR CRITICAL VETERINARY MEDICAL PRODUCTS 62
4.1 SUMMARY OF RESIDUE STANDARDS FOR CRITICAL VETERINARY MEDICAL
PRODUCTS 62
4.2 ADDITIONAL INFORMATION PER CRITICAL VETERINARY MEDICAL PRODUCT 63
1
Product Standards 3/71
17 March 2010 GMP+ International
Introduction
1.1 General
The GMP+ Feed Safety Assurance scheme (GMP+ FSA) has been developed since 1992. It was managed from 1992 up until 2009 by the Product Board Animal Feed, The Hague, The Netherlands. Since 2010, this scheme is managed by GMP+ International.
It is a scheme for assuring feed safety in all the links in the feed chain. It is also an international scheme, applicable worldwide.
The establishment and development of the scheme was primarily the result of de- mand from the subsequent links in the animal production chain for better control of feed safety. Another contributory factor was the damage caused by more and less serious contamination incidents.
In the initial phase the demand arose for better differentiation in an increasingly saturated European sales market for animal products. Since 1999, feed & food safety has been a top issue internationally both politically and commercially, be- cause of serious incidents in the feed sector. Because of this, demonstrable assur- ance of feed safety has become a sales prerequisite.
The basic principle of the GMP+ FSA scheme is that the feed chain is part of the food production chain. Proper assurance of feed safety worldwide is a high priority. Companies must live up to their responsibilities and respond properly and convinc- ingly to the needs of animal production. The GMP+ FSA scheme is an aid to realise this.
1.2 Structure of the GMP+ Feed Safety Assurance scheme
The documents within the GMP+ FSA scheme are subdivided into a number of series. A description follows of these:
AGeneral (framework) docu-
ments
These documents contain the requirements for participation in the certification scheme for com- panies and certification bodies (framework regu- lation, the use of logo‟s, etc.). This series also includes a general list of definitions and abbre- viations.
Product Standards 4/71
17 March 2010 GMP+ International
BNormative documents.
These documents contain the international standards and additional country notes for use by companies with respect to the various feed products and production phases including culti- vation and industrial production, treatment and processing, collection, trade, means of trans- port, storage and transhipment.
These documents are divided in several subgroups, with a code and a name
Document Code NameStandard GMP+ Bxx
Appendix
Country Note
GMP+ BAxx
GMP+ BCNxx
e.g. GMP+ BA1 Product Standards
CCertification requirements
These documents contain the Rules of Certifica- tion including those for the approval of certifica- tion bodies and auditors, the frequency of au- dits, minimum audit time, assessment criteria, checklists, etc. There is also an explanation of how the supervision by certification bodies is implemented and of how GMP+ International supervises the certification process.
D Interpretations and accompa- nying texts
In addition to the above-mentioned standarda- tive documents, there are also supporting documents in the D series including a list of fre- quently-asked questions, manuals and guid- ances with additional information.
All these documents are available through the website of GMP+ International(ww w . g m p pl us. or g ) .
The document in the present case is referred to as appendix GMP+ BA1 ProductStandards and is part of the GMP+ FSA scheme. It has a structure of its own.
GMP+ Appendices (GMP+ BAxx), to which there are also references, are separate GMP+ documents within the B segment of the GMP+ FSA Scheme. If there is a reference to such a GMP+ BAxx-appendix, then it applies within the framework of this standard. GMP+ BAxx-appendices are indicated as such.
Next to this, also reference to a number of other appendices may be made. These appendices are in that case only part of this document, and are attached to it. To indicate them, only the word „appendix‟ is used.
Product Standards 5/71
17 March 2010 GMP+ International
PART A: PRODUCT STANDARDS
1 Introduction to the product standards
There are references in the various GMP+ standards to the product standards.
This part of this appendix contains the statutory and GMP+ standards with respectto contaminants. The product standards included in this appendix area. based on the statutory standards for products in the European Union or na-
tionally (the Netherlands), orb. as determined within the framework of the GMP+ FSA scheme in consultation
with the subsequent links in the animal production chain.
The following standards apply in addition to those in the tables:the list of permitted additives in the Netherlands in accordance with Directive (EC) No. 1831/2003 and the residue standards in part B of this appendix.
DISCLAIMER: The GMP+ International has adopted this list in order to inform in- terested parties with respect to the standards in the legislation (European Union and national) and additional GMP+ standards. The list will be regularly updated. The GMP+ International is not liable for any errors in this list.
2 Conditions
In arriving at the standards a distinction has been made between action and rejec- tion limits. The action limits for undesirable contaminants is appreciably lower than the rejection limit.
A c t i on li m i t :A feasible limit agreed in consultation with the sector, supplier or customer. Where the action limit is exceeded an investigation must be carried out into the:a. source of the contamination and measures must be taken to b. remove or limit the source of the contamination.
R e j ecti o n li m it :A feasible limit agreed in consultation with the sector, supplier or customer. If the rejection limit is exceeded then the product is not suitable for use as a feed mate- rial or animal feed.
In the various GMP+ standards it is stated that the participant must ensure that deviations (in the product or process) from the requirements in this standard are recorded and controlled in order to prevent unintentional use or delivery of the product.
S t a n d a r d f or m i x es o f f e ed m a t eri al s ( sem i -m a n u f act u r ed p r o d u c t ) w h i ch a r e ma r- k e t ed as such
Product Standards 6/71
17 March 2010 GMP+ International
The standard for the maximum level of undesirable substances is calculated pro- portionately from the standard for the individual components. This calculation prin- ciple is also applied for the calculation of the standard for pesticides for compound feeds (see section 4.2.4 question no.5).
Product Standards 7/71
17 March 2010 GMP+ International
3 Summary GMP+ product standards for the animal feed sector
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
Microbiological
M1 Antibacterial inhibition - Feed materials - < 15 mm GMP+ According to the 5-plate
test MB003, derived from
EG-4-plate test, product
basis (RIVM report no.
206; Archiv fur Lebensmit-
telhygiene 31 (1981) page
97-140.
OZM Part 1; O-1
- Wet mixes
M3 Enterobacteriaceae Feed for pets and dog bones - 300 kve/gram Reg. 1774/2002 n = 5, c = 2, m = 10, M =
300 in 1 gram , 14 Tinned
feed for pets which has
been subjected to heat
treatment with a Fc value
of at least 3
does not necessarily have
to be sampled and tested
for Salmonella and En-
terobacteriaceae.
OZM Part 2; M-3
M4a Salmonella Consumption chick feed: end products
and feed materials for:
- Top breeding consumption chicks - 0+% 20(approaching 0%)
- Breeding increase consumption chicks - 0+% 20(approaching 0%)
GMP+ OZM Part 2; M-2a
to M2e
Product Standards 8/71
17 March 2010 GMP+ International
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
Microbiological
- Increase consumption chicks - 0+% 20(approaching 0%)
- Consumption chicks - 0+% 20(approaching 0%)
Laying poultry feed: end products and
feed materials for:
- Top breeding laying poultry - 0+% 20(approaching 0%)
- Raising increase laying poultry - 0+% 20(approaching 0%)
- Increase laying poultry - 0+% 20(approaching 0%)
- Laying-hens and breeding hens 1% 0+% 20(approaching 0%)
for S. enteritidus and S.
typhimurium
Turkey feed: end products and feed
materials for:
- Raising increase turkeys - 0+% 20(approaching 0%)
- Increase turkeys - 0+% 20(approaching 0%)
- Consumption turkeys - 0+% 20(approaching 0%)
GMP+
GMP+
Other animal feeds, feed materials and
wet mixes intended for cattle farms
(except for poultry feeds).
- Absent in 25 gr GMP+
Feed for pets and dog bones - Absent in 25 gr Reg. 1774/2002 n = 5, c = 0, m = 0, M = 014 Tinned feed for pets
which has been subjected
to heat treatment with a
Fc value of at least 3
Product Standards 9/71
17 March 2010 GMP+ International
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
Microbiological
M4b Salmonella preservation
determined through pH- Feed materials for delivery to cattle
farms, and
- Wet mixes for delivery to livestock
farmers on the basis of:
- Spontaneous lactic acid fermentation
- Add organic acids
- Add anorganic acids
Maximum pH for guar-
antee:
- 4.5
4
3,5
does not necessarily have
to be sampled and tested
for Salmonella and En-
terobacteriaceae.
GMP+If preservation can be achieved at a higher pHthen this should be sup- ported with data.
These standards do not
apply if the products are
supplied at a temperature
of at least 60°C and the
supplier is demonstrably
informed of the storage
conditions.
OZM Part 2; M-5
M5 Moulds - Feed materials for delivery to cattle
farms, and
- Wet mixes for delivery to cattle farm-
ers
with an Aw value > 0.75 (if this is not
known then a moisture content > 13%)
The absence of Salmo-
nella can also be shown in
heat-treated wet mixes
and feed materials (<13%
moisture) through compli-
ance with the standards
for Enterobacteriaceae,
- 10,000 kve/gram GMP+ OZM Part 2; M-4
Product Standards 10/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
C1 Aflatoxin B1 Feed materials intended for (direct)
delivery to dairy farmers
- 0.005 mg/kg GMP+ OZM Part 2;
OSP1a to 1e
All feed materials - 0.02 mg/kg Directive
2003/100/EEGComplete animal feeds for cattle, sheep
and goats with the exception of:
- 0.02 mg/kg amending Directive
2002/32/EEG
- dairy cattle - 0.005 mg/kg
- calves and lambs - 0.01 mg/kg
Complete animal feeds for pigs and
poultry (with the exception of young
animals)
- 0.02 mg/kg
Other complete animal feeds - 0.01 mg/kg
Supplementary animal feeds for cattle,
sheep and goats (with the exception of
supplementary animal feeds for dairy
cattle, calves, lambs)
Supplementary animal feeds for pigs
and poultry (with the exception of young
animals)
- 0.02 mg/kg
- 0.02 mg/kg
Other supplementary animal feeds - 0.005 mg/kg
Product Standards 11/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
C2 Aldrin } separately
} or
} jointly
} expressed in
Dieldrin }dieldrin
all animal feeds, with the exception of: - 0.01 mg/kg Directive
2002/32/EG
- fats and oils, 0,1 mg/kg Directive
OZM Part 2; OSP-
11
- fish feed 0.2 mg/kg 2006/77/EEG
amending Directive
2002/32/EEG
C3 Arsenic16, 2 Feed materials, with the exception of: - 2 mg/kg Directive
2003/100/EEG
OZM Part 2; OSP-
26
- ground grass meal, alfalfa meal and
clover meal and also molassed and
unmolassed dried sugar beet pulp
- 4 mg/kg amending Directive
2002/32/EEG
Directive
- Palm kernel flakes - 4 mg/kg15
- phosphates and limestone - 10 mg/kg
- calcium carbonate - 15 mg/kg
- magnesium oxide - 20 mg/kg
2009/141/EC
amending Annex I
to Directive
2002/32/EC
- animal feeds obtained by processing
fish or other sea creatures, including fish
- 15 mg/kg15
25 mg/kg15
- ground dried seaweed and feed mate-
rials on the basis of seaweed
- 40 mg/kg15
Product Standards 12/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
Iron particles used as tracer - 50 mg/kg
Additives belonging to the functional
group of compounds of trace elements
except:
- copper sulphate pentahydrate and
copper carbonate
- zinc oxide, manganese oxide and
copper oxide
Complete animal feeds, with the excep-
tion of:
- complete fish feed and complete ani-
mal feed for fur-bearing animals
Complementary animal feeds, with the
exception of:
- 30 mg/kg
- 50 mg/kg
- 100 mg/kg
- 2 mg/kg
- 6 mg/kg15
10 mg/kg15
- 4 mg/kg
- mineral mixes - 12 mg/kg
C4 Prussic acid Feed materials, with the exception of: - 50 mg/kg Directive
2002/32/EG
OZM Part 2; OSP-9
- linseed - 250 mg/kg
- linseed cake - 350 mg/kg
- cassava products and almond cake, - 100 mg/kg
complete animal feeds, with the excep-
tion of:
- 50 mg/kg
- complete animal feeds for chicks - 10 mg/kg
Product Standards 13/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
C5 Biogenic amines* - Animal feeds> 30% crude protein - 4,000 mg/kg. protein GMP+ * In as far as these are
created by decay due to
protein decay and are not
the consequence of the
standard processing of the
product
C6 Cadmium 2 Feed materials of vegetable origin, - 1 mg/kg Directive
2005/87/EEG
OZM Part 2; OSP-
23
OZM Part 2; OSP-
27
Feed materials of animal origin - 2 mg/kg amending Directive
2002/32/EEG
Feed materials of mineral origin, with the
exception of:
2 mg/kg
- phosphates - 10 mg/kg
Feed additives, belonging to the func-
tional group "Compounds of trace
elements", with the exception of:
- copper oxide, manganese (II)oxide,
zinc oxide and manganese (II) sulphate-
monohydrate
Feed additives belonging to the func-
tional group "Binding agents and thin-
ners"
- 10 mg/kg
- 30 mg/kg8
- 2 mg/kg
Premixes - 15 mg/kg8
Mineral mixes
- containing < 7% phosphorus - 5 mg/kg
- containing> 7% phosphorus - 0.75 mg/kg per 1%
phosphorus, with a
maximum of 7.5 mg/kg
Additional animal feeds for pets - 2 mg/kg
Product Standards 14/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
Other supplementary animal feeds - 0.5 mg/kg
Complete animal feeds for cattle, sheep
and goats and fish feed with the excep-
tion of:
- 1 mg/kg
- complete pet feeds - 2 mg/kg
- complete animal feeds for calves,
lambs and goat lambs and other com-
plete animal feeds
- 0.5 mg/kg
C7 Chloride - Feed materials for delivery to cattle
farms, and
10 g/kg (dry
matter)
10x the action limit (dry
matter) 21GMP+
If the action limit is ex- ceeded then a warning orprocessing advice must be demonstrably commu- nicated to the customer.
OZM deel 2; OSP-
22
- Wet mixes for delivery to cattle farm-
ers.
C8 Chlorocamphene
(toxaphene) – sum of
the indicators CHB 26,
50 and 627
Fish, other sea creatures and
(by)products thereof with the exception
of fish oil
- 0.02 mg/kg Directive
2005/86/EEG
amending Directive
2002/32/EEG
OZM Part 2; OSP-
11
- fish oil8 - 0.2 mg/kg
- fish food8 - 0.05 mg/kg
C9 Chlordane (sum of cis-
en transisomers and of
oxychlordane expressed
in Chlordane)
all animal feeds, with the exception of: - 0.02 mg/kg Directive
2002/32/EG
- fats and oils - 0.05 mg/kg Directive
2006/77/EEG
amending Directive
2002/32/EEG
OZM Part 2; OSP-
11
Product Standards 15/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
C10 Crotalaria spp. All animal feeds - 100 mg/kg Directive
2002/32/EG
Microscopic deter- mination in accor- dance with the instructions of the manufacturer
C11 DDT (sum of DDT-,
DDD- (or TDE-) and
DDE-isomers, ex-
pressed in DDT)
all animal feeds, with the exception of: - 0.05 mg/kg Directive
2008/76/EEG
amending Directive
2002/32/EEG
- fats en oils - 0.5 mg/kg
OZM Part 2; OSP-
11
C12 Animal proteins Animal feeds for productive livestock - 0 Regulation (EC)
no. 1234/2003 to
amend
999/2001/EG, art. 7
and Appendix IV
See GMP+ Appendix 3:
Negative list
OZM Part 2; OSP-
12
C13a Dioxin 11 + 18 Feed materials of vegetable origin with
the exception of vegetable oils and their
by-products
0.5 ng WHO-
PCDD/F-
TEQ/kg4 + 17
0.75 ng WHO-PCDD/F-
TEQ/kg4 + 5
Directive
2006/13/EG to
amend Directive
2002/32/EEG
In the event of exceeding
the action limit: Determi-
nation of the source of the
contamination. Once the
source of the contamina-
tion has been established
take, if possible, suitable
measures to reduce or
eliminate this
OZM Part 2; OSP-
18
Product Standards 16/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
Vegetable oils and their by-products 0.5 ng WHO-
PCDD/F-
TEQ/kg4 + 17
Feed materials of mineral origin 0.5 ng WHO-
PCDD/F-
TEQ/kg4 + 17
0.75 ng WHO-PCDD/F-
TEQ/kg4 + 5
1.0 ng WHO-PCDD/F-
TEQ/kg4 + 5
In the event of exceeding
the action limit: Determi-
nation of the
source of the contamina-
tion. Once the source of
the contamination has
been established take, if
possible, suitable meas-
ures to reduce or elimi-
nate thisIn the event of exceeding the action limit: Determi- nation of the source of the contamination. Once the source of the contamina- tion has been established take, if possible, suitable measures to reduce or eliminate this
Animal fat including milk fat and egg fat 1.0 ng WHO-
PCDD/F-
TEQ/kg4 + 17
2,0 ng WHO-PCDD/F-
TEQ/kg4 + 5
In the event of exceeding
the action limit: Determi-
nation of the source of the
contamination. Once the
source of the contamina-
tion has been established
take, if possible, suitable
measures to reduce or
eliminate this
Product Standards 17/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
Products from other than land animals
including milk, milk products, eggs and
products from eggs
0,5 ng WHO-
PCDD/F-
TEQ/kg4 + 17
0,75 ng WHO-PCDD/F-
TEQ/kg4 + 5
In the event of exceeding
the action limit: Determi-
nation of the source of the
contamination. Once the
source of the contamina-
tion has been established
take, if possible, suitable
measures to reduce or
eliminate this
Fish oil 5.0 ng WHO-
PCDD/F-
TEQ/kg4 + 17
6.0 ng WHO-PCDD/F-
TEQ/kg4 + 5
In the event of exceeding
the action limit: In many
cases it may perhaps not
be necessary to carry out
an investigation into the
source of the contamina-
tion as the background
level in some areas is
close or above the action
level.
Fish, other sea creatures and their
(subsidiary) products , with the exception
of fish oil and fish protein hydrolysates
which contain more than 20% fat6
1.0 ng WHO-
PCDD/F-
TEQ/kg4 + 17
1.25 ng WHO-PCDD/F-
TEQ/kg4 + 5
If the action limit is really
exceeded then all the
details such as the sam-
pling period, geographical
origin, fish species,
Product Standards 18/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
Fish protein hydrolysates which contain
more than 20% fat6
Fish food
Feeds for pets
The feed additives kaolinite-bearing clay,
calcium sulphate hydrate, vermiculite,
natrolite phonolite, synthetic calcium
aluminates and clinoptilolite of sedimen-
tary origin, belonging to the functional
group "Binding agents and thinners"
Feed additives belonging to the func-
tional group "Binding agents and thin-
ners"
1.75 ng WHO-
PCDD/F-
TEQ/kg4 + 17
1.75 ng WHO-
PCDD/F-
TEQ/kg4 + 17
0.5 ng WHO-
PCDD/F-
TEQ/kg4 + 17
2.25 ng WHO-PCDD/F-
TEQ/kg4 + 5
2.25 ng WHO-PCDD/F-
TEQ/kg4 + 5
0.75 ng WHO-PCDD/F-
TEQ/kg4 + 5
etc., should be recorded
with a view to future
measures for the pres-
ence of dioxins
and dioxin-like com-
pounds in these animal
feeds
In the event of exceeding
the action limit: Determi-
nation of the source of the
contamination. Once the
source of the contamina-
tion has been established
take, if possible, suitable
measures to reduce or
eliminate this
Feed additives belonging to the func-
tional group "Trace elements com-
pounds"
0.5 ng WHO-
PCDD/F-
TEQ/kg4 + 17
1.0 ng WHO-PCDD/F-
TEQ/kg4 + 5
Product Standards 19/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
Premixes 0.5 ng WHO-
PCDD/F-
TEQ/kg4 + 17
1.0 ng WHO-PCDD/F-
TEQ/kg4 + 5
In the event of exceeding
the action limit: Determi-
nation of the source of the
contamination. Once the
source of the contamina-
tion has been established
take, if possible, suitable
measures to reduce or
eliminate this
C13b Sum of dioxins and
dioxin-like PCBs12 +18
Compound feeds with the exception of
feeds for fur-bearing animals and pets
and of fishfeed
Feed materials of vegetable origin with
the exception of vegetable oils and their
by-products
0.5 ng WHO-
PCDD/F-
TEQ/kg4 + 17
0.75 ng WHO-PCDD/F-
TEQ/kg4 + 5
1.25 ng WHO-PCDD/F-
PCB-TEQ/kg 4
In the event of exceeding
the action limit: Determi-
nation of the source of the
contamination. Once the
source of the contamina-
tion has been established
take, if possible, suitable
measures to reduce or
eliminate this
OZM Part 2; OSP-
18
Vegetable oils and their by-products 1.5 ng WHO-
PCDD/F- PCB-
TEQ/kg 4
Feed materials of mineral origin 1.5 ng WHO-PCDD/F-
PCB-TEQ/kg 4
Animal fat including milk fat and egg fat 3.0 ng WHO-PCDD/F-
PCB-TEQ/kg 4
Product Standards 20/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
Products from other than land animals
including milk, milk products, eggs and
products from eggs
1.25 ng WHO-PCDD/F-
PCB-TEQ/kg 4
Fish oil 24.0 ng WHO-PCDD/F-
PCB-TEQ/kg 4
Fish, other sea creatures and their
(subsidiary) products , with the exception
of fish oil and fish protein hydrolysates
which contain more than 20% fat6
Fish protein hydrolysates which contain
more than 20% fat
Feed additives belonging to the func-
tional group "Binding agents and thin-
ners"
4.5 ng WHO-PCDD/F-
PCB-TEQ/kg 4
11 ng WHO-PCDD/F-
PCB-TEQ/kg 4
1.5 ng WHO-PCDD/F-
PCB-TEQ/kg 4
Feed additives belonging to the func-
tional group "Trace elements com-
pounds"
1.5 ng WHO-PCDD/F-
PCB-TEQ/kg 4
Premixes 1.5 ng WHO-PCDD/F-
PCB-TEQ/kg 4
Compound feed with the exception of
feeds for fur-bearing animals and pets
and of fishfeed
Fish food
Feeds for pets
1.5 ng WHO-PCDD/F-
PCB-TEQ/kg 4
7.0 ng WHO-PCDD/F-
PCB-TEQ/kg 4
Product Standards 21/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
C13c Dioxin-like PCBs19 +18 Feed materials of vegetable origin with
the exception of vegetable oils and their
by-products
0.35 ng WHO-
PCB-TEQ/kg 4
+ 17
In the event of exceeding
the action limit: Determi-
nation of the source of the
contamination. Once the
source of the contamina-
tion has been established
take, if possible, suitable
measures to reduce or
eliminate this
OZM Part 2; OSP-
18
Vegetable oils and their by-products 0.5 ng WHO-
PCB-TEQ/kg 4
+ 17
Feed materials of mineral origin 0.35 ng WHO-
PCB-TEQ/kg 4
+ 17
In the event of exceeding
the action limit: Determi-
nation of the source of the
contamination. Once the
source of the contamina-
tion has been established
take, if possible, suitable
measures to reduce or
eliminate this
In the event of exceeding
the action limit: Determi-
nation of the source of the
contamination. Once the
source of the contamina-
tion has been established
take, if possible, suitable
measures to reduce or
eliminate this
Product Standards 22/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
Animal fat including milk fat and egg fat 0.75 ng WHO-
PCB-TEQ/kg 4
+ 17
In the event of exceeding
the action limit: Determi-
nation of the source of the
contamination. Once the
source of the contamina-
tion has been established
take, if possible, suitable
measures to reduce or
eliminate this
Products from other than land animals
including milk, milk products, eggs and
products from eggs
0.35 ng WHO-
PCB-TEQ/kg 4
+ 17
In the event of exceeding
the action limit: Determi-
nation of the source of the
contamination. Once the
source of the contamina-
tion has been established
take, if possible, suitable
measures to reduce or
eliminate this
Fish oil 14.0 ng WHO-
PCB-TEQ/kg 4
+ 17
In the event of exceeding
the action limit: In many
cases it may perhaps not
be necessary to carry out
an investigation into the
source of the contamina-
tion as the background
level in some areas is
close or above the action
level.
Product Standards 23/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
Fish, other sea creatures and their
(subsidiary) products , with the exception
of fish oil and fish protein hydrolysates
which contain more than 20% fat
Fish protein hydrolysates which contain
more than 20% fat
2.5 ng WHO-
PCB-TEQ/kg 4
+ 17
7.0 ng WHO-
PCB-TEQ/kg 4
+ 17
If the action limit is really
exceeded then all the
details such as the sam-
pling period, geographical
origin, fish species, etc.,
should be recorded with
a view to future measures
for the presence of dioxins
Fish food
Feeds for pets
Feed additives belonging to the func-
tional group "Binding agents and thin-
ners"
3.5 ng WHO-
PCB-TEQ/kg 4
+ 17
0.5 ng WHO-
PCB-TEQ/kg 4
+ 17
and dioxin-like com-
pounds in these animal
feeds
In the event of exceeding
the action limit: Determi-
nation of the source of the
contamination. Once the
source of the contamina-
tion has been established
take, if possible, suitable
measures to reduce or
eliminate this
Feed additives belonging to the func-
tional group "Trace elements com-
pounds"
0.35 ng WHO-
PCB-TEQ/kg 4
+ 17
In the event of exceeding the action limit: Determi- nation of the source of the contamination. Once the source of the contamina- tion has been established take, if possible, suitable measures to reduce or eliminate this
Product Standards 24/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
Premixes 0.35 ng WHO-
PCB-TEQ/kg 4
+ 17
In the event of exceeding
the action limit: Determi-
nation of the source of the
contamination. Once the
source of the contamina-
tion has been established
take, if possible, suitable
measures to reduce or
eliminate this
Compound feed with the exception of
feeds for fur-bearing animals and pets
and of fishfeed
0.5 ng WHO-
PCB-TEQ/kg 4
+ 17
In the event of exceeding
the action limit: Determi-
nation of the source of the
contamination. Once the
source of the contamina-
tion has been established
take, if possible, suitable
measures to reduce or
eliminate this
C15 DON Animal feed on full ration basis for: GMP+ OZM Part 2; OSP-
19
(Deoxynivalenol) - Pigs 0.8 mg/kg 1 mg/kg
- Cattle 4 mg/kg 5 mg/kg
- Calves up to 4 months 1.6 mg/kg 2 mg/kg
- Dairy cattle 2.4 mg/kg 3 mg/kg
- Poultry 3.2 mg/kg 4 mg/kg
Product Standards 25/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
Feed material (supplied to the cattle
farmer for immediate feeding) for
- Pigs 1 mg/kg 5 mg/kg
- Cattle 5 mg/kg 15 mg/kg
- Calves up to 4 months 2 mg/kg 6 mg/kg
- Dairy cattle 3 mg/kg 9 mg/kg
- Poultry 4 mg/kg 12 mg/kg
GMP+ The supplier provides
information to the cattle
farmer in the event of
infringement of the action
limit for the level of the
undesirable substance
and provides advice on
processing the product in
the days ration
C16 Endosulfan (sum of alfa
and bèta-isomers and of
all animal feeds, with the exception of: 0.1 mg/kg Directive
2003/100/EEG
OZM Part 2; OSP-
11
endosulfan sulphate,
expressed in endosul-
- maize and derived products - 0.2 mg/kg amending Directive
2002/32/EEG
fan)- oil-bearing seeds and derived products
with the exception of crude vegetable oil
- 0.5 mg/kg Directive
2006/77/EEG
amending Directive
2002/32/EEG
C17 Endrin (sum of endrin
and deltaketo-endrin,
expressed in endrin)
- crude vegetable oil - 1,0 mg/kg
- complete fish food - 0.005 mg/kg
All animal feeds, with the exception of: - 0.01 mg/kg Directive
2002/32/EG
- fats and oils - 0.05 mg/kg Directive
2006/77/EEG
amending Directive
2002/32/EEG
OZM Part 2; OSP-
11
C19 Fluorine 3 Feed materials, with the exception of: - 150 mg/kg Directive
2005/87/EEG
amending Directive
2002/32/EEG
OZM Part 2; OSP-6
Product Standards 26/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
- animal feeds of animal origin with the
exception of sea water shellfish such as
krill
- 500 mg/kg
- seawater shellfish such as krill - 3,000 mg/kg
- phosphates - 2,000 mg/kg
- calcium carbonate - 350 mg/kg
- magnesium oxide - 600 mg/kg
- calcareous marine algae - 1,000 mg/kg
Vermiculite (E 561) - 3,000 mg/kg8 Directive
2008/76/EEG
amending Annex I
to Directive
2002/32/EEG
Supplementary animal feeds
- containing> 4% phosphorus - 500 mg/kg
- containing > 4% phosphorus - 125 mg/kg per 1%
phosphorus
complete animal feeds, with the excep-
tion of:
- complete animal feeds for cattle, sheep
and goats
- 150 mg/kg
- which suck - 30 mg/kg
- others - 50 mg/kg
- complete animal feeds for pigs - 100 mg/kg
- complete animal feeds for poultry - 350 mg/kg
- complete animal feeds for chicks - 250 mg/kg
Product Standards 27/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
C20 Heptachlor (sum of
heptachlor and hepta-
chlor epoxyd, expressed
in heptachlor)
C21 Hexachlorobenzene
(HCB)
- complete animal feeds for fish - 350 mg/kg Directive
2008/76/EEG
amending Annex I
to Directive
2002/32/EEG
All animal feeds, with the exception of: - 0.01 mg/kg Directive
2002/32/EG
- fats and oils - 0.2 mg/kg Directive
2006/77/EEG
amending Directive
2002/32/EEG
All animal feeds, with the exception of: - 0.01 mg/kg Directive
2002/32/EG
- fats and oils - 0.2 mg/kg Directive
2006/77/EEG
amending Directive
2002/32/EEG
OZM Part 2; OSP-
11
OZM Part 2; OSP-
11
C22 Hexachlorocyclohexane
(HCH):
- Directive
2002/32/EG
OZM Part 2; OSP-
11
- Alfa-isomer All animal feeds, with the exception of: - 0.02 mg/kg
- fats and oils - 0.2 mg/kg Directive
2006/77/EEG
amending Directive
2002/32/EEG
- Beta-isomer Compound feeds with the exception of: - 0.01 mg/kg
- feeds for dairy cattle - 0.005 mg/kg
Product Standards 28/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
Feed materials, with the exception of: - 0.01 mg/kg
- fats and oils - 0.1 mg/kg Directive
2006/77/EEG
amending Directive
2002/32/EEG
- Gamma-isomer (lin-
dane)
All animal feeds, with the exception of: - 0.2 mg/kg
- fats and oils - 2.0 mg/kg Directive
2006/77/EEG
amending Directive
2002/32/EEG
C23 Potassium - Feed materials for delivery to cattle
farms, and
- Wet mixes for delivery to cattle farm-
ers
60 g/kg (dry
matter)
10x the action limit (dry
matter) 21
GMP+ If the action limit is
exceeded then a warning
or processing advice must
be demonstrably commu-
nicated to the customer.
OZM deel 3; WM-
08
C24 Hydrocarbons (C10-
C40)
Animal fat, with the exception of: - 400 mg/kg (on product
basic)
- crude fish oil - 3,000 mg/kg (on product
basic)
GMP+ OZM Part 2; OSP-
15a
Vegetable oil (with the exception of
sunflower oil)
- 400 mg/kg (on product
basic)
Sunflower oil and sunflower fatty acids - 1,000 mg/kg (on product
basic)
Product Standards 29/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
Vegetable fatty acids incl. Mixes of fatty
acids (with the exception of sunflower
fatty acids)
- 3,000 mg/kg (on product
basic)
Palm oil - 25 mg/kg calculated as
diesel oil
This standard applies if
the hydrocarbons (calcu-
lated as diesel oil) are
determined via the GC-
MS method. If use is
made of the GC-FID
method, then the standard
for vegetable oil applies
OZM Part 2; OSP-
15b
Hydrocarbons (mineral
paraffin/oil) : saturated
hydrocarbons in the
range C10-C56 from
external sources minus
the alkanes C27, C29
and C31
Sunflower oil (falling within CN code
15121191 or TARIC Code 1512199010)
originating in or consigned from Ukraine
50 mg/kg (on product
basic)
Commission Deci-
sion 2008/388/EC
of 23 May 2008
Commission Regu-
lation 1151/2009 of
27 November 2009
Temporary standard. In
one year the situation will
be re-assessed. The
batch must be accompa-
nied by a report of analy-
sis and a Health certificate
The method of
detection GC-FID
(flame ionisation
detector) is prefer-
able, but the GC-
MS can be used as
well. The sampling
has to be per-
formed in accor-
dance with Com-
mission Regulation
(EC) No 333/2007
and the standard
ISO5555:2003 and
the analysis by a
laboratory accred-
ited according to
EN ISO/IEC 17025
Product Standards 30/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
C25 Copper (E4) Free-range consumption pig feed - 25 mg/kg total GMP+ Only for free-range con-
sumption pig feed
OZM Part 1; TVM-
I-2
Pigs: 13 - Commission Regu-
lation (EC) No- Piglets to 12 weeks 13 - 170 mg/kg total 1334/2003 amend-
- Other pigs 13 - 25 mg/kg total
Cattle: 13
1. Cattle before they start with rumina-
tion:
- Milk replacer13 - 15 mg/kg total
- Other complete animal feeds13 - 15 mg/kg total
ing the conditions
for authorisation of
a number of addi-
tives in feed-
ingstuffs belonging
to the group of
trace elements
2. Other pigs 13 - 35 mg/kg total
- Sheep13 - 15 mg/kg Total
- Fish13 - 25 mg/kg total
- Shellfish13 - 50 mg/kg total
- Other animals13 - 25 mg/kg total
C26 Mercury2, 16 Feed materials, with the exception of: - 0.1 mg/kg Directive
2005/8/EEG
OZM Part 2; OSP-5
- animal feeds obtained by processing
fish or other aquatic animals
- 0.5 mg/kg amending Directive
2002/32/EEG
Product Standards 31/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
- calcium carbonate - 0.3 mg/kg Directive
2010/6/EU amend-
ing Annex I to
Directive
2002/32/EC
Compound (complementary and com-
plete) animal feeds, with the exception
of:
- complete animal feeds for dogs and
cats
- 0.1 mg/kg
- 0.4 mg/kg
- mineral feed - 0.2 mg/kg
- compound feedingstuffs for fish - 0,2 mg/kg
complete animal feeds, with the excep-
tion of:
- compound feedingstuffs for dogs, cats
and fur animals
- supplementary animal feeds for dogs
and cats
- 0.2 mg/kg
0,3 mg/kg
- -
C27 Lead10 Feed materials, with the exception of: - 10 mg/kg Directive
2005/87/EEG
amending Directive
2002/32/EEG
OZM Part 2; OSP-
28
- green fodder 9 - 30 mg/kg8
- phosphates and limestone - 15 mg/kg
- calcium carbonate - 20 mg/kg
- yeast - 5 mg/kg
Product Standards 32/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
Feed additives, belonging to the func-
tional group "Compounds of trace
elements", with the exception of:
100 mg/kg
- zinc oxide 400 mg/kg8
- manganese (II)oxide, ferrous carbon-
ate, copper carbonate
Feed additives, belonging to the func-
tional group "Binding agents and thin-
ners", with the exception of:
200 mg/kg8
30 mg/kg8
- clinoptilolite of vulcanic origin 60 mg/kg8
Premixes 200 mg/kg8
complete animal feeds, with the excep-
tion of:
- 10 mg/kg
- mineral mixes - 15 mg/kg
Complete animal feeds - 5 mg/kg
C28 Ergot of rye (Claviceps
purpurea)
All animal feeds which contain unground
grain
- 1,000 mg/kg Directive
2002/32/EG
OZM Part 2; OSP-
32
C29 Sodium - Feed materials for delivery to cattle
farms, and
- Wet mixes for delivery to cattle farm-
ers
8 g/kg (dry
matter)
10x the action limit (dry
matter) 21
GMP+ If the action limit is
exceeded then a warning
or processing advice must
be demonstrably commu-
nicated to the customer.
OZM deel 3; WM-
09
C30 Nickel Feed fats 20 mg / kg (on
a fat basis)
50 mg / kg (on a fat
basis
GMP+ OZM Part 2; OSP-
29
Product Standards 33/71
17 March 2010 GMP+ International
Product Standards
17 March 2010
34/71
GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
C31 Nitrites Feed materials, with the exception of: - 15 mg/kg (expressed in
sodium nitrite)
- Fish meal - 60 30 mg/kg (expressed
in sodium nitrite)
- silage - -
Directive
2005/8/EEG
amending Directive
2002/32/EEG
Directive
2010/6/EU amend-
ing Annex I to
Directive
OZM Part 2; OSP-7
Complete animal feeds, with the excep-
tion of:
- feeds for pets with the exception of
birds and aquarium fish
complete feedingstuffs for dogs and cats
with a moisture content exceeding 20 %.
- 15 mg/kg (expressed in
sodium nitrite)
- -
2002/32/EC
C32 Weed seeds and un-
ground or pulverised
fruits which contain
alkaloids, glucosides or
other poisonous sub-
stances separately or
jointly, including:
- Datura stramonium L.
sp.
All animal feeds - 3,000 mg/kg Directive
2002/32/EG Direc-
tive 2009/141/EC
amending Annex I
to Directive
2002/32/EC
- 1,000 mg/kg
Microscopic deter-
mination in accor-
dance with the
instructions of the
manufacturer
C33 Insoluble impurities Melted fats from ruminants - 0,15% Regulation
1774/2002
OZM Part 2; OSP-
16
C34 Ochratoxin A Animal feed on full ration basis for: GMP+ OZM Part 2; OSP-
19
Product Standards
17 March 2010
35/71
GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
- sows and consumption pigs and piglets 0.04 mg/kg 0.05 mg/kg
- poultry 0.16 mg/kg 0.2 mg/kg
Feed material (supplied to the cattle
farmer for immediate feeding) for
- Sows and pigs and piglets 0.05 mg/kg 0.15 mg/kg
- Poultry 0.2 mg/kg 0.6 mg/kg
The supplier provides
information to the cattle
farmer in the event of
infringement of the action
limit for the level of the
undesirable substance
and provides advice on
processing the product in
the days ration
C35 Polycyclic Aromatic
Hydrocarbons (PAHs)
Feed fats 15 μg/kg
BaPEQ
50 μg/kg BaPEQ GMP+ BaPEQ = Benzo(a)pyrene
equivalent
OZM Part 2; OSP-
33
(on fat basis) (on fat basis)
C38 Ricinus-Ricinus commu-
nis L.
Seeds and husks from
Ricinus communis L.,
Croton tiglium L. and
Abrus precatorius L. as
well as their processed
derivatives [4], sepa-
rately or in combination
All animal feeds - 10 mg/kg (expressed in
ricinus husks)
Directive
2002/32/EG
Directive
2009/141/EC
amending Annex I
to Directive
2002/32/EC
Microscopic deter-
mination in accor-
dance with the
instructions of the
manufacturer
pigs
- complete animal feeds for dogs, rab-bits, horses and fur
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
C39 Sulphate - Feed materials for delivery to
cattle farms, and
- Wet mixes for delivery to cattle farm-
ers which are preserved with sulphuric
acid and not for products which by
nature are rich in sulphur
8 g/kg (dry
matter)
10x the action limit (dry
matter) 21
GMP+ If the action limit is ex-
ceeded then a warning or
processing advice must
be demonstrably commu-
nicated to the customer.
OZM deel 2; OSP-
24
C40 Theobromine complete animal feeds, with the excep-
tion of:
- 300 mg/kg Directive
2002/32/EG
OZM Part 2; OSP-8
- complete animal feeds for full-grown
cattle- 700 200 mg/kg
- 50 mg/kg
Directive
2009/141/EC
amending Annex I
to Directive
2002/32/EC
C41 Vinylthiooxazolidon Complete animal feeds for poultry
with the exception of:
- 1,000 mg/kg Directive
2002/32/EG
OZM Part 2; OSP-
31
(Vinyloxazolidine thion) - complete animal feeds for laying
poul- try- 500 mg/kg
C42 Volatile mustard oil Feed materials, with the exception of: - 100 mg/kg Directive
2002/32/EGOZM Part 2; OSP-
20
- colza cakes - 4,000 mg/kg (calculated
as allylisothiocyanate)
complete animal feeds, with the excep-
tion of:
- Complete animal feeds for cattle,
sheep and goats (with the exception of
young animals)
- 150 mg/kg (calculated
as allylisothiocyanate)
- 1,000 mg/kg (calculated
as allylisothiocyanate)
- Complete animal feeds for pigs (with
the exception of piglets) and poultry
- 500 mg/kg (calculated
as
all
yli
so
thi
oc
ya
na
te
)
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
C43 Free gossypol Feed materials, with the exception of: - 20 mg/kg Directive
2005/8/EEG
OZM Part 2; OSP-
21
- cotton seed - 5,000 mg/kg
- cotton seed cake and cotton seed meal - 1,200 mg/kg
amending Directive
2002/32/EEG
Directive
Complete animal feeds, with the excep-
tion of:
- complete animal feeds for adult cattle,
sheep and goats
- 20 mg/kg
- 500 mg/kg
2010/6/EU amend-
ing Annex I to
Directive
2002/32/EC
- complete feedingstuffs for sheep
(except lambs) and goats (except kids),
- 300 mg/kg
- complete animal feeds for poultry
(except laying hens) and calves
- 100 mg/kg
- complete animal feeds for rabbits,
lambs, kids and pigs (except piglets)- 60 mg/kg
C44 Zearalenon Animal feed on full ration basis for: GMP+ OZM Part 2; OSP-
19
- sows and consumption pigs 0.2 mg/kg 0.25 mg/kg
- young pigs 0.08 mg/kg 0.1 mg/kg
- young cattle and dairy cattle 0.4 mg/kg 0.5 mg/kg
Feed material (supplied to the cattle
farmer for immediate feeding) for
- sows and pigs 0.25 mg/kg 0.75mg/kg
- young pigs 0.1 mg/kg 0.3 mg/kg
The supplier provides information to the cattle farmer in the event of infringement of the action limit for the level of the undesirable substance and provides advice on processing the product in the days ration
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
- young cattle and dairy cattle 0.2 mg/kg 1.5 mg/kg
C45 Zinc (E6) Free-range consumption pig feed - 90 mg/kg total GMP+ Only for free-range con-
sumption pig feed
OZM Part 1; TVM-
I-4
Pets13 - 250 mg/kg total Commission Regu-
lation (EC) No1334/2003 amend-
Fish13
- 200 mg/kg totaling the conditions for authorisation of a number of addi-
Milk replacer13 - 200 mg/kg total
Other animals13 - 150 mg/kg total
tives in feed- ingstuffs belonging to the group of trace elements
C46 Melamine - All feeds which contain milk and milk products, soya or soya products originat- ing from or sent from China.
- 2,5 mg/kg Commission Deci- sion 2008/921/EC of9 December 2008 amending Commis- sion Decision2008/798/EG of 14October 2008.
All batches from China or feeds sent from China which contain milk and milk products, soya or soya products must be tested for Melamine. See Commission Decision
Commission Regula- 2008/798/EC for completetion (EC) No1135/2009 of 25November 2009
information. Identity and physical checks, including sampling and analysis to control the presence of melamine, shall be carried out on approximately 20% of such consignments.
- Ammonium bicarbonate intended for use in feeds originating from or sent from China.
- 2,5 mg/kg - All batches from Chinaor ammonium bicarbonate from China intended for use in feeds must be tested for Melamine. Identity and physical checks, including sam- pling and analysis to control the presence of melamine, shall be carried out on approximately 20% of such consignments.
Product Standards 38/71
17 March 2010 GMP+ International
Chemical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
- All other feeds originating in China which have a high protein content.
- 2,5 mg/kg Random checks may be carried out to control the presence of melamine on other feeds which have originated in China and which have a high protein content before the prod- ucts are imported into the EU.
Physical
F1 Plastics - Feed materials for delivery to
cattle farms, and
- 1.5 g/kg (dry matter
basis)
GMP+ Via manual separation
and weighing
Microscopic deter-
mination in accor-
dance with the
instructions of the
manufacturer
- Wet mixes for delivery to cattle farm-
ers
F2 Polyethylene - Feed materials for delivery to cattle
farms, and
0.25 g/kg (on
fat basis)
This standard was in-
cluded subject to the
outcome of the discussion
taking place in the Euro-
pean Commission.
0.5 g/kg (on fat basis) GMP+ OZM Part 2; OSP-
13
- Wet mix for delivery to cattle farmers
Product Standards 39/71
17 March 2010 GMP+ International
Physical
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
F5 Beech, unpeeled seeds
- Fagus silvatica (L.)All animal feeds
- Seeds and fruits of the
adjacent plant types
and the by-products
Directive
2002/32/EG
F6 Chinese mustard –
Brassica juncea (L.)
Czern. and Coss. ssp.
juncea var. lutea Batalin
F7 Ethiopian mustard –
Brassica carinata A.
Braun
-obtained from process-
ing may not appear in
animal feeds unless as
traces which can not- be quantitatively de-
termined
F8 Indian brown mustard -
Brassica juncea (L.)
Czern. and Coss. ssp.
integrifolia (West.) Thell.
F9 Mowrah, Bassia, Mad-
huca – Madhuca longifo-
lia (L.) Macbr. (=Bassia
longifolia L. = Illipe
malabrorum Engl.)
Madhuca indica Gmelin
(= Bassia latifolia
(Roxb.) = Illipe latifolia
(Roscb.) F. Mueller)
-
- Directive
2005/8/EEG
amending Directive
2002/32/EEG
Directive
2010/6/EU amend-
ing Annex I to
Directive
2002/32/EC
F10 Physic nut - Jatropha -
curcas L.
Product Standards 40/71
17 March 2010 GMP+ International
Contaminant Product Action limit(1) Rejection limit(1) Source Supplementary require-
ments
Analysis method7
F11 Physic croton - Croton -
tiglium L.
F12 Sarepta mustard - -
Brassica juncea (L.)
Czern. and Coss. ssp.
juncea
F14 Black mustard – Bras- -
sica nigra (L.) Koch
Product Standards 41/71
17 March 2010 GMP+ International
Product Standards
17 March 2010
42/71
GMP+ International
[*1 ] A c t i o n l i m i t : A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then an investigation into the cause should be undertaken and corrective measures should
be taken to remove or control that cause. Maximum levels in mg/kg (ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently.
R e j e c t ion l i m i t : A feasible limit agreed in consultation with the sector, supplier or customer. If this limit is exceeded then the product is not suitable for use as feed material or animal feed. Maximum levels in mg/kg
(ppm) of the feed materials or compound feeds, derived to a moisture content of 12% unless mentioned differently.
[2] The maximum levels refer to an analytical determination of arsenic/ cadmium / mercury where the extraction is done for 30 minutes a boiling temperature in Nitric acid (5% m/m). Equivalent extraction
proce- dures may be used where it can be demonstrated that the extraction procedure used has the same extraction efficiency
[3] The maximum levels refer to an analytical determination of fluorine where the extraction is done for 20 minutes at an ambient temperature with hydrochloric acid 1 N. Equivalent extraction procedures may
be used where it can be demonstrated that the extraction procedure used has the same extraction efficiency
[4] Upper limit concentrations; in the calculation of upper limit concentrations it must be assumed that values lying under the detection limits for the various congenors are equal to the detection limit.
[5] The individual maximum level for dioxins (PCDD/Fs) remains temporarily applicable. The values specified in item C13a for products intended for feeding to animals must correspond in this period to the
maxi- mum levels for dioxins and the maximum levels for the sum of dioxins and dioxin-like PCBs.
[6] Fresh fish which is supplied directly without any further processing and used for the production of feeds for fur-bearing animals gebruikt, is exempted from the maximum level, and for fresh fish which is used
for the direct feeding of pets, zoo animals and circus animals there is a maximum level of 4.0 ng WHO-PCDD/F-TEQ/kg product and 8.0 ng WHO-PCDD/F-TEQ/kg product. The products, processed animal
proteins from these animals (fur-bearing animals, pets, zoo animals and circus animals), may not get into the feed chain and the feeding of them to productive livestock which are kept for the production
foodstuffs, are being fattened up or bred, is forbidden.
[7] The research methods (OZM) can be found via the ww w . pd v. nl ; quality; research methods)
[8] The levels will be reviewed before 31 December 2007 with a view to lowering the maximum levels
[9] Green fodder includes products which are intended for feeding to animals such as hay, silage, fresh grass, etc.
[10] The maximum levels refer to an analytical determination of lead where the extraction is done for 30 minutes a boiling temperature in Nitric acid (5% m/m). Equivalent extraction procedures may be used
where it can be demonstrated that the extraction procedure used has the same extraction efficiency
[11] (sum of the polychlorinated dibenzo-para dioxins (PCDDs) and the polychlorinated dibenzofurans (PCDFs) expressed in toxicity equivalents established by the World Health Organisation (WHO) where use
is made of the WHO-TEFs (toxicity equivalence factors from 1997)
[12] (sum of the polychlorinated dibenzo-para dioxins (PCDDs) and the polychlorinated dibenzofurans (PCDFs) and the polychlorinated biphenyls (PCBs) expressed in toxicity equivalents established by the World
Health Organisation (WHO) where use is made of the WHO-TEFs (toxicity equivalence factors from 1997)
[13] If the GMP+ standard for this product and the animal type in question is lower than the standard specified here, then the GMP+ standard applies. In complete animal feed
[14] n = number of samples to be tested; m = threshold value for the number of bacteria; the results will be considered to be satisfactory if the number of bacteria in none of the samples is greater than m, M =
maximum value for the number of bacteria in one or more samples is equal to or greater than M, c = number of samples for which the bacteria count gives a result between m and M and where the sample is
still considered acceptable if the result of the bacteria for the other samples is not higher than m.
[15] At the request of the competent authorities the responsible operator must carry out an analysis to show that the level of inorganic arsenic is lower than 2 ppm. This analysis is especially important for the
Hizikia fusiforme seaweed
[16] The maximum levels refer to the total level of arsenic / mercury
[17] The Commission will evaluate these action limits at the same time as the maximum levels for the sum of dioxins and dioxin-like PCBs before 31 December 2008.
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[18] TEF's from the WHO for the assessment of the risks to humans based on the conclusions of the meeting of the World Health Organisation in Stockholm, Sweden, 15-18 June 1997 (van den Berg et al., (1998)
Toxic Equivalence Factors (TEF's) for PCB's, PCDD's, PCFD's for Humans and for Wildlife Environmental Health Perspectives, 106(12), 775).
Congenor TEF Value Congenor TEF Value
Dibenzo-p-dioxins (PCDDs)
2,3,7,8-TCDD
1,2,3,7,8-PeCDD
1,2,3,4,7,8-HxCDD
1,2,3,4,7,8-HxCDD
1,2,3,4,7,8-HxCDD
1,2,3,4,6,7,8-HpCDD
OCDD
Dibenzofuranes (PCDFs)
2,3,7,8-TCDF
1,2,3,7,8-PeCDF
2,3,4,7,8-PeCDF
1,2,3,4,7,8-HxCDF
1,2,3,6,7,8-HxCDF
1,2,3,7,8,9-HxCDF
2,3,4,7,8-HxCDF
1,2,3,4,6,7,8-HpCDF
1,2,3,4,7,8,9-HpCDF
OCDF
1
1
0.1
0.1
0.1
0.01
0.0001
0.1
0.05
0.5
0.1
0.1
0.1
0.1
0.01
0.01
0.0001
Dioxin-like PCBs
Non-ortho-PCBs + mono-ortho-PCBs
Non-ortho-PCB'
PCB 77
PCB 81
PCB 126
PCB 169
Mono-ortho-PCBs
PCB 105
PCB 114
PCB 118
PCB 123
PCB 156
PCB 157
PCB 167
PCB 189
0,0001
0,0001
0,1
0,01
0,0001
0,0005
0,0001
0,0001
0,0005
0,0005
0,00001
0,0001
Key to abbreviations: T= tetra; Pe= penta; Hx=hexa; Hp= hepta; O= octa; CDD= chlordibenzodioxin; CDF= chlordibenzofuran; CB= chlorbiphenyl
[19] (sum of the polychlorinated biphenyls (PCBs) expressed in toxicity equivalents established by the World Health Organisation (WHO) where use is made of the WHO-TEFs (toxicity equivalence factors from
1997)
[20] Explanation of 0+: this standard does not apply to each individual sample. In a particular period of time the Salmonella incidence at company level should approach 0% (=
0+). [21]The rejection limits do not apply to feeds such as salt or mineral licks which are deliberately supplied with high mineral levels.
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4 Residue levels of pesticides in feeds
4.1 Introduction
A start was made in April 2005 in the EU on the revision of the community legisla- tion with respect to the permitted maximum levels of residues of pesticides by way of R e g u l ati o n ( EG ) N o. 3 9 6/200 5 . This regulation includes the maximum residue levels (MRL) for simple products of vegetable and animal origin intended for human consumption and for feeds. In as much as the MRLs apply to feeds they are appli- cable to both feeds for food-producing animals and for non-food-producing animals.
The layout of the standard is such that in many cases it is not possible immediately to indicate a standard for a certain combination of feed / pesticide. This chapter indicates:a. How the correct standard for a simple, untreated/unprocessed product can be
out-of-date;b. How the correct standard for a derived product can be determined;c. How the correct standard for a compound feed can be determined;d. Which special requirements apply.
4.2 The establishment of and MRL
4.2.1 G e n eral
The MRLs (maximum residue levels) are established for simple products. Many of these MRLs are to be found on “Pesticides Web”, a database which was created by the EC. (h t t p : // e c . e u r o p a . e u / sa n c o _ p e s t i c i d e s / p u b li c / i n d e x . c fm ? e v e n t =sub s t a n c e . s e l ecti o n & ch=1) This is almost always the untreated form of a product. This means that anumber of calculations must be carried out both for the determination of the MRL in a derived product (for example, sunflower oil, maize gluten meal) and for the de- termination in compound products (compound feeds, supplementary feeds).
The correct standard can be determined using the enclosed questionnaires. The basic principle of the questionnaires is that there is a known pesticide and that the associated residue standard must be found for a particular feed.
The questionnaires have been drawn up so that you always are led to a result. The following questionnaires are available.a. Questionnaire for basic products.
This questionnaire helps you determine the MRL for basic products. b. Questionnaire for by-products.
This questionnaire helps you determine the MRL for auxiliary products. c. Questionnaire for compound feeds.
This questionnaire helps you determine the MRL for compound feeds.
It is of great importance to note here that Regulation (EC) No. 396/2005 only ap- plies to products of vegetable or animal origin! If this is not the case then any stan- dards in Di r e c t i v e 200 2 / 3 2/EG s till apply.
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To make this chapter easier to read the questionnaire makes use of the definitions in the following table.
Table 1: Definitions and questionnaires
Product group Definition Questionnaire
Basic product Simple, unprocessed product of vegetable or animal origin (wheat,
barley, linseed, sunflower seeds, soya bean, peas, shrimps)
4.2.2.
Auxiliary products Simple, treated/processed or derived product, originating from an
basic product. (flour, semolina pellets, potato press fibres, soya
flakes, linseed oil, peapod meal, fish meal)
4.2.3
Compound feed Compound product consisting of at least two components being basic
products, by-products and/or feed additives. (complete feed, supple-
mentary feed, petfood, grain mixes, premixes)
4.2.4.
NOTE: These definitions have only been drawn up to improve the readability ofChapter 4 and have no value or legitimacy outside this chapter.
The questionnaires help you to determine the standard. You are not always imme- diately led to a number or value. It could be that you are referred to another point in a table or to another table. It may also be possible that you have to carry out a few calculations.
For a limited number of products (table 2) the MRL in Regulation (EC) No.396/2005 may not (yet) apply for parts of these products are given the exclusive destination animal feed. For these products the MRLs for pesticides therefore still apply as specified in the Directive 2002/32/EG.
Table 2: Product (groups) of which parts with the exclusive destination animal feed are not (yet) covered under
Reg. 396/2005
Product (groups)Fish, fish products, crus-taceans and shellfish and other products from salt and fresh water creatures*
Kohl-rabi foliage Palm hearts Palm kernels
Only for crops used for feed*
Garden cress Fungi Palm fruits
Loquats Winter cress Seaweed KapokCherimoya‟s Rucola Lupines (dried) MilletGuavas Red amsoi Shells, seeds and possi-
bly skins of oil-retaining seeds and fruits (such as soya hulls)
Sorghum
Bread fruits Leaves and sprouts ofBrassica spp.
Borage Coffee beans
Durians Purslain Pumpkin seed Herbal teaSoursops (durian blanda) Vine leaves Hemp seed Cacao beanArrowroot Herbs (sage, rosemary,
thym, basi, laurel, tarra- gon)
Camelina Carob
Nut shells Lentils (fresh) Safflower seed SpicesSprouts stems Bamboo shoots Olives (oil recovery) Sugar crops
* : The standards of Reg. 396/2005 apply neither to feeds nor to foodstuffs for (parts of) products in these groups.
For all other products of vegetable or animal origin, Regulation (EC) No. 396/2005 applies.
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4.2.2 Q u e s t i o n n ai r e f o r b a s i c p r o d u c t s
1. Is your basic product in Table 2 and does it have the exclusive destination animal feed?
Yes This new regulation does not yet apply to your basic product.Check if Directive 2002/32/EG contains a standard for your basic product / pesticide combination (end).
No Go to question 2.
2. Is your basic product included in A p p e n d i x I o f Reg. 396/2005, either as anIndividual product (column 3, 4 and 5) or as a group of products (column 2)?
Yes Go to question 3.No Your basic product is probably not a simple untreated / Un-
processed product of vegetable or animal origin. Check your product using the definitions in Table 1. Consult your sup- plier.
3. Is your basic product individually included in A p p e n d i x I o f Reg. 396/2005, (column 3, 4 and 5)
Yes Go to question 4.No Go to question 7.
4. Is the pesticide for which you are looking for a standard included in P e s t i- c i d e s W e b , the online EU pesticides database?
Yes Go to question 5.No Go to question 6.
5. On P e s t i c i d e s W e b select the languiage you want, your basic product and the pesticide for which you want the MRL. Click on the button “Search cur- rent MRL”. You have found the standard. Place the mouse cursor on the MRL or click on the pesticide for additional information (end).
6. Is the pesticide included in Appendix V of Reg. 396/2005?Yes You have found the standard for the pesticide. Carefully read
any footnotes which apply to the standard (end).No The pesticide is not specified.The standard amounts to 0.01
mg/kg for basic products. (end)Note: At the time of the first publication of this document Appendix V was not yet completed
7. Is the pesticide for which you are looking for a standard included in P e s t i- c i d e s W e b , the online EU pesticides database?
Yes Go to question 8.No Go to question 9.
8. On P e s t i c i d e s W e b select the languiage you want, the (sub) group of prod- ucts to which your basic product belongs and the pesticide for which you want the MRL. Click on the button “Search current MRL”. You have found the standard. Place the mouse cursor on the MRL or click on the pesticide for additional information (end).
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9. Is the pesticide included in Appendix V of Reg. 396/2005?Yes You have found the standard for the pesticide. Carefully read
any footnotes which apply to the standard (end).No The pesticide is not specified.The standard amounts to 0.01
mg/kg for basic products. (end)
NOTE: At the time of the first publication of this document Appendix V was not yet completed
4.2.3 Q u e s t i o n n ai r e f o r b y - pr o d u c t s
1. Is your by-product from a product / product group in table 2 and does it have the exclusive destination animal feed?
Yes This new regulation does not yet apply to your basic product.Check if Di r e c t i v e 200 2 / 3 2/EG co ntains a standard for your basic product / pesticide combination (end).
No Go to question 2.
2. Is your by-product included in A p p e n d i x I o f Reg. 396/2005, either as a by- product (column 2 in combination with 3, 4 or 5) or as a group of products (column 2) or in the form of the original product?
Yes Go to question 3.No Your by-product is probably not a product of vegetable or
animal origin. Check your product using the definitions in Ta- ble 1. Consult your supplier.
3. Is your by-product from that part of the (derived) product or the product group for which the MRL applies (Reg. 396/2005, A p p e n d i x I , column 6)?
Yes The standards in this regulation apply to your by-product. Goto question 4.
No This new regulation does not yet apply to your by-product.Check if Di r e c t i v e 200 2 / 3 2/EG co ntains a standard for your by-product/pesticide combination (end).
You have established that the standards from this regulation apply to your by- product. You thenuse the questionnaire for basic products (4.2.2.) question 3 and further, todetermine the standard for your individually-specified by-product, the origi- nal product or the relevant product group. Now proceed with question 4 in this questionnaire.
4. Is the by-product for which the standard is established equal to the by- product for which you are looking for a standard?
Yes The standard you have found is the standard for this by-product / pesticide combination. (end)
No Go to question 5.
5. In Reg. 396/2005, Appendix VI, is there a concentration or dilution factor established for your by-product or for the treatment / processing which is the basis for your by-product?
Yes Use this factor to determine the final standard for this by- product / pesticide combination. (end)
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No Go to question 6.
NOTE: At the time of the first publication of this document Appendix VI was not yet completed
6. Is the treatment / processing for this by-product based on the separation of a fat and water fraction?
Yes Go to question 7.No The processing / treatment has no effect on the residue level,
the standard whichyou have found is the final standard for this by- product/pesticide combination. (end)
Your by-product has been created as a result of the separation of a fat-oil fraction and a fat-oil free fraction (pressing, extraction). In the rest of this questionnaire you determine if there is an accummulation of residues in the fat fraction or in the fat- free fraction
7. Does the name of the pesticide in P estic i d e n W e b have the suffix (F)?Yes The pesticide is soluble in fat. Determine, using the fat per-
centage in the original product and in your by-product, the di- lution or concentration factor (see table 3) and divide or mul- tiply this by the standard found for the original product(group) in order to determine the final standard.(end)
Table 3: Concentration factors for many vegetable oils which are used
Oil-retaining basic product Avg. oil levelConcentration
factor in oil
Palm fruit 50 2
Sheanut 50 2
Coconut 50 2
Palm kernel 49 2
Sesame seed 49 2
Peanut 48 2
Rapeseed 40 2
Linseed 45 2
Sunflower seeds 32 3
Kardi / Safflower seed 31 3
Cotton seed 20 5
Soya bean 19 5
Grape seed 15 6
Source: Product Board for Margarine, Fats and Oils (MVO), Memorandum Crude Oils
MRLs, Sept. 2003
No Go to question 8.
8. Search on I n t ern a t i o n al C h e m i cal S a f ety C ar d s ( ICSC s) f or the pesticide in question and note the “Octanol/water partition coefficient” (log Pow) which you will find in the chapter “Physical properties”. The log Pow is a measure of the solubility in water or fat of the pesticide. Is the log Pow greater than4?
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Yes The pesticide is soluble in fat. Determine, using the fat per- centage in the original product and in your by-product, the di- lution or concentration factor and divide or multiply this by the standard found for the original product(group) in order to de- termine the final orm.(end)
No Go to question 9.9. Is the log Pow between 3 and 4?
Yes The pesticide is not specifically soluble in water or fat. There is no Dilution or concentration of the pesticide residue as a Result of the treatment to which the original product was sub- jected. The standard which you found in the P est i c i d e s W e b also applies to your by-product. (end)
No Go to question 10.
10. The log Pow is less than 3. The pesticide is soluble in water. Use the fat percentage in the original product and your by-product to determine the dilu- tion or concentration factor and divide or multiply this by the the standardyou found for the original product or product group in order to determine the final standard.(end). Note: In this case, where there is a pesticide which issoluble in water, there is dilution of the fat fraction and concentration of the fat-free fraction!
NOTE: the method described in this section for the determination of maximum resi- due limits (MRL) in fats and oils also applies to fatty acids.
4.2.4 Q u e s t i o n a i r e f o r c o m p o u nd f e e ds
1. Specify the individual components of your compound feed. In Reg.396/2005, Appendix VI, has a concentration or dilution factor has been es- tablished foryour compound feed, A certain fraction of your compound feed. A by-product that is part of your copound feed?
Yes Use this factor or factors to determine the final standard for this specific part of your compound feed and to determine the pesticide in ques-tion. Go to question 2 .No Go to question 2.
NOTE: At the time of the first publication of this document Appendix VI was not yet completed
2. Does your compound feed contain basic products among other things?Yes For each of these components go through the questionnaire
in par. 4.2.2. In order to determine the standards for these components. Go to question 3
No Go to question 3.
3. Your compound feed contains (among other things) by-products. For each of these components go through the questionnaire in par. 4.2.3. In order to determine the standards for these components. Go to question 4.
4. Have you determined a standard for all the components for which a stan- dard has been set and have you taken account of the factors laid down in question 1?
Yes Go to question 5.No Go through this questionnaire again starting at question 1
5. Now determine the MRL for the specific pesticide in the compound feed in the following way
MRLx = {(NxC1 * C1) + (NxC2 * C2) …. + (NxCn * Cn)}/ ΣC1:Cn
Where: MRLx : Is the maximum residue standard for pesticide X in the compound feed
NxCn : The standard found for the component / group of components C (1 to n)
Cn : The percentage in the compound feed for compo- nent / group of components C (1 to n)
ΣC1:Cn: The sum of the percentages of components for which an MRL for pesticide X actually applies
4.2.5 F u m i g a t ors
It is permitted to trade feeds which at the moment of sale exceed an MRL for a pes- ticide specified in Appendix II or III of Reg. 396/2005. This relates to an excess as a result of treatment of feeds with gaseous pesticides (gas generation, fumigation) after harvesting. The pesticides for which this permission applies and also the products involved are specified in A p p e n d i x V I I o f Reg. 396/2005.
4.3 Special requirements
In addition to the standards for undesirable substances which have a broad validity within the feed chain, some specific measures are announced with some regularity for precisely-defined products or product groups. These are often temporary meas- ures as a result of very specific contamination. The following measures are cur- rently in force.
D ec i s i on 2 0 0 8 / 3 5 2/ E G o f 29/04/08 adopting special requirements for guar flour originating or sent from India due to the risks of contamination of this product with pentachlorophenol and dioxins.
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PART B: RESIDUE STANDARDS
1 INTRODUCTION
In addition to compliance with the adopted standards in appendix 1, part A, the participant must also comply with the (residue) levels of additives and veterinary medical products. Please refer to the definition of feed safety as laid down in the list of definitions for the GMP+ Feed Safety Assurance scheme.
The participant must ensure thata. the correct additives and veterinary medical products get into the right feed in
the right dosage (GMP+ B1, section 6.7.1.2).b. (residues of) additives and veterinary medical products are not present or are
under set maximum limits (the so-called residue standards) in feeds in which they should not be present (GMP+ B1, section 6.7.1.5).
In order to be able to control the residue levels the participant should, among other things, measure carry-over in the installations (see Appendix 4) and establish production sequences. In chapter 2 of part B of this appendix there are further instructions for this.
Chapter 3 of part B of this appendix states the maximum residue standards for coccidiostats, histomonostats and critical veterinary medical products. These standards apply to compound feeds, semi-manufactured products, feed materials and premixtures and are applicable to producers of these products.
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Carried out by TNO-Nutrition2 Additional provisions
2.1 General
The control of residue levels using the production sequence is shown in diagram form in the following table.
Carry-over measurement
instruction (Appendix 4)
Wall adhesion factor measurement
instruction
Relative wall adhesion factor measurement
Installation internal carry-over
Coefficient factor (Appendix 1, Part B,
Chapter 3)
Coefficient (=carry-over
x factor)
Carry-over percentage
Max. residue norm(Appendix 1, Part
B, Chapter 3) Calculation
Production sequence / flush
batches
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2.2 Compound feed
2.2.1 I nsta ll ati o n C a rr y - o v er l e v e l :
The installation‟s own carry-over is the carry-over measured using an inspection procedure as laid down in GMP+BA4 Minimum Requirements for Sampling and Analysis.
The fr e q u e ncy at which the carry-over must be measured is determined as follows:a. If the participant processes or transports (animal feed containing) feed addi-
tives for which a residue standard has been determined in the table in Chapter3 or veterinary medical products then the degree of carry-over must be knownfor the lines on which these products are processed.
b. If the participant has relevant 1 lines then he must measure carry-over at least once per two years.
c. The minimum frequency for the measurement of carry-over may be lowered toonce per year on condition that:1. the carry over measured is less than 10% and2. as soon as the last measurement is over two years old, the participant
must assume the degree of carry over of the line in question is 15%.
The carry-over must be re-established in the event of major changes to the installa- tion.
2.2.2. T he co e f f i c i e n t
The coefficient is intended to take account of an extra carry-over in addition to the installation carry-over, as a consequence of the processing properties of the addi- tive or veterinary medicine. A factor of 1 means that the product contains no proc- essing properties other than those of a standard measurement substance. The ac- tual carry-over of the product therefore corresponds to the installation carry-over. If the factor is greater than 1, this means that the product has anomalous processing properties, such that the actual carry-over will be higher than the installation carry- over.
The coefficient is determined on the basis of a so-called relative wall adhesion fac- tor using a method specially developed for this purpose. Refer to TNO report I-96-31006 Carry-over of a number of critical substances in cattle feed and the relation- ship to their characteristic properties.
1Relevant lines are lines on which (products with) feed additives for which a residue norm has
been determined in the table in Chapter 3 or veterinary medical products and also products with a
de- termined residue norm are produced and/or transported.
Relative wall adhesive factor according to the established method.
Coefficient
< 1 1> 1 and < 2 2> 2 and < 3 2,5
unknown, > 3 3
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The relationship between the relative wall adhesion factor and the co-efficient is shown in the following table.
2.2.3. C ar r y - o v er a n d f l u sh b a t ch e s
The actual carry-over of additives and carry-over or veterinary medical products must be calculated in order to establish the number of flushes. This carry-over can be calculated by multiplying the installation carry-over by the coefficient.
This coefficient can be used to calculate how many flush batches are minimally required to remain under the established residue standards. A sample calculation follows.
Example:Broiler feed with nicarbazine : 80 ppm Company‟s own carry-over in installation: : 5 % Coefficient : "1" Maximum residue standard for broiler feedfor the last five days: : 0.5 ppm
Calculation of actual carry-over = company‟s own carry-over x coefficient= 0.05 (5%) x 1 = 0.05
Calculation: c a l c u l a ted l e v e l of n i c arb a z i ne - batch a broiler feed 80 ppm- batch a+1 follow-on feed 4 ppm (= 0.05 x 80)- batch a+2 follow-on feed 0.2 ppm (= 0.05 x 4)
The second batch complies with the residue standard for broiler feed in the final fattening phase. Therefore a first flush batch must be produced with a non-critical feed.
2.2.4 It e m s f or a t t e n t i on a n d o t h e r r em ar k s
The supplementary instructions for use relate to the sequence of production opera- tions in the installation. It is also necessary for the participant to establish company requirements and procedures in order to comply with the residue standards for:a. transport (sequence) and storage (sequence)b. intake of premixes, additives and veterinary medical products.
The participant must check that the prescribed residue standards are not ex- ceeded. If an infringement of these residue standards is detected, the instructions for use and procedures must be modified.The coefficients and the minimum carry-over levels calculated from them may bedeviated from provided that the carry-over is measured using the relevant product itself.
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2.3 Premix
2.3.1 G e n eral
The objective of these supplementary instructions is that compound feed producers must be able to use premixes from GMP+-certified manufacturers in producing compound feeds, without exceeding the maximum carry-over levels.
Carry-over of critical additives and veterinary medicines also occurs in the prepara- tion of premixes. In order to prevent GMP+-certified compound feed mixers from exceeding the standards for coccidiostats, histomonostats and critical veterinary medical products because of excessive levels in premixes, a general rule of thumb is that no more than 50% of the residue standard as stated for compound feed may be used up as a result of the premixes used.The maximum level in the premix must be derived from the dosage of the premix inthe compound feed. Carry-over of coccidiostats, histomonostats and critical veteri- nary medical products may take place via direct and indirect contamination.
2.3.2 Di r ect co n t a m i n a t i on
Direct contamination is possible through use of a premix destined for an animal feed for which a maximum residual level has been established. The premix pro- ducer is to ensure through his GMP+ feed safety system that no more than 50% of the residue standard as stated for that compound feed is used up via the premix.
For any flush batches required, the relevant coefficient as established for that prod- uct should be adopted.
2.3.3 I n di r ect co n t ami n ati o n
In order to achieve extremely low residue standards in premixes, producers of pre- mixes will have to first produce a number of batches for a non-critical use following the production of premixes with coccidiostats, histomonostats and critical veterinary medicines. A premix which is produced subsequent to one prepared with a coc- cidiostats or histomonostats (a so-called flush batch) may still contain such high levels of coccidiostats or histomonostats that this can cause problems for the com- pound feed producer.Compound feed manufacturers use these premixes mainly in animal feeds whichare also used to flush an installation clean. In certain cases the level of critical addi- tives is so high that, together with the company‟s own carry-over levels, the residue standards in compound feeds are exceeded.
Product standards
17 March 2010
56/71
GMP+ International
3 Residue standards for critical additives
3.1 Summary of residue standards for coccidiostats and histomonostats according to Directive 2002/32/EC amending Annex I to Directive2002/32/EC
Additives Products intended for animal feed (2) Maximum content in
mg/kg (ppm) relative to a
feedingstuff with a
moisture content of 12 %
Lasalocid sodium
Feed materials 1,25
Compound feed for:- dogs, calves, rabbits, equine species, dairy animals, laying birds, turkeys (> 12 weeks) and chickens reared for laying (> 16 weeks)
1,25
- chickens for fattening, chickens reared for laying (< 16 weeks) and turkeys (< 12 weeks) for the period before slaughter in which the use of lasalocid sodium is prohibited (with- drawal feed)
1,25
- other animal species 3,75
Premixtures for use in feed in which the use of lasalocid sodium is not authorised
(3)
Narasin Feed materials 0,7
Compound feed for:
- turkeys, rabbits, equine species, laying birds and chickens reared for laying (> 16 weeks)
0,7
- chickens for fattening for the period before slaughter in which the use of narasin is pro- hibited (withdrawal feed)
0,7
- other animal species 2,1
Premixtures for use in feed in which the use (3)
2 Without prejudice to the authorised levels in the frame of Regulation (EC) No 1831/2003 of the
European Parliament and of the Council of 22 September 2003 on additives for use in animal
nutri- tion.3
The maximum level of the substance in the premixture is the concentration which shall not result in a
level of the substance higher than 50 % of the maximum levels established in the feed when
the instructions for use of the premixture are followed.
Product standards
17 March 2010
57/71
GMP+ International
Additives Products intended for animal feed (2) Maximum content in
mg/kg (ppm) relative to a
feedingstuff with a
moisture content of 12 %
of narasin is not authorised.
Salinomycin sodium
Feed materials 0,7
Compound feed for:- equine species, turkeys, laying birds and chickens reared for laying (> 12 weeks)
0,7
- chickens for fattening, chickens reared for laying (< 12 weeks) and rabbits for fattening for the period before slaughter in which the use ofsalinomycin sodium is prohibited (withdrawal feed)
0,7
- other animal species 2,1
Premixtures for use in feed in which the use of salinomycin sodium is not authorised.
(3)
Monensin sodium
Feed materials 1,25
Compound feed for:
- equine species, dogs, small ruminants (sheep and goat), ducks, bovine, dairy cattle, laying birds, chickens reared for laying (> 16 weeks) and turkeys (> 16 weeks)
1,25
- chickens for fattening, chickens reared for laying (< 16 weeks) and turkeys (< 16 weeks) for the period before slaughter in which the use of monensin sodium is prohibited (with- drawal feed)
1,25
- other animal species 3.75
Premixtures for use in feed in which the use of monensin sodium is not authorised.
(3)
Semduramici n sodium
Feed materials 0.25
Compound feed for:
- laying birds and chickens reared for laying(> 16 weeks)
0,25
- chickens for fattening for the period before 0,25
Product standards
17 March 2010
58/71
GMP+ International
Additives Products intended for animal feed (2) Maximum content in
mg/kg (ppm) relative to a
feedingstuff with a
moisture content of 12 %
slaughter in which the use of semduramicin sodium is prohibited (withdrawal feed)
- other animal species 0,75
Premixtures for use in feed in which the use of semduramicin sodium is not authorised.
(3)
Maduramicin ammonium alpha
Feed materials 0,05
Compound feed for:- equine species, rabbits, turkeys (> 16 weeks), laying birds and chickens reared for laying (> 16 weeks)
0,05
- chickens for fattening and turkeys (< 16 weeks) for the period before slaughter in which the use of maduramicin ammonium alpha is prohibited (withdrawal feed)
0,05
- other animal species 0,15
Premixtures for use in feed in which the use of maduramicin ammonium alpha is not authorised.
(3)
Robenidine hydro- chloride
Feed materials 0,7
Compound feed for:- laying birds and chickens reared for laying(> 16 weeks)
0,7
- chickens for fattening, rabbits for fattening and breeding and turkeys for the period be- fore slaughter in which the use of robenidine hydrochloride is prohibited (withdrawal feed)
0,7
- other animal species 2,1
Premixtures for use in feed in which the use of robenidine hydrochloride is not authorised.
()
Decoquinate Feed materials 0,4
Compound feed for:
- laying birds and chickens reared for laying 0,4
Product standards
17 March 2010
59/71
GMP+ International
Additives Products intended for animal feed (2) Maximum content in
mg/kg (ppm) relative to a
feedingstuff with a
moisture content of 12 %
(> 16 weeks)
- chickens for fattening for the period before slaughter in which the use of decoquinate is prohibited (withdrawal feed)
0,4
- other animal species 1,2
Premixtures for use in feed in which the use of decoquinate is not authorised
(3)
Halofuginone hydro- bromide
Feed materials 0,03
Compound feed for:
- laying birds, chickens reared for laying (> 16 weeks) and turkeys (> 12 weeks)
0,03
- chickens for fattening and turkeys (< 12 weeks) for the period before slaughter in which the use of halofuginone hydrobromide is prohibited (withdrawal feed)
0,03
- other animal species other than chickens reared for laying (< 16 weeks)
0,09
Premixtures for use in feed in which the use of halofuginone hydrobromide is not author-ised
(3)
Nicarbazin Feed materials 0,5
Compound feed for:
- equine species, laying birds and chickens reared for laying (> 16 weeks)
0,5
- chickens for fattening for the period before slaughter in which the use of nicarbazin (in combination with narasin) is prohibited (with- drawal feed)
0,5
- other animal species 1,5
Premixtures for use in feed in which the use of nicarbazin (in combination with narasin) isnot authorised
(3)
Diclazuril Feed materials 0,01
Product standards
17 March 2010
60/71
GMP+ International
Additives Products intended for animal feed (2) Maximum content in
mg/kg (ppm) relative to a
feedingstuff with a
moisture content of 12 %
Compound feed for:
- laying birds, chickens reared for laying (> 16 weeks) and turkeys for fattening (> 12 weeks)
0,01
- rabbits for fattening and breeding for the period before slaughter in which the use of diclazuril is prohibited (withdrawal feed).
0,01
- other animal species other than chickens reared for laying (< 16 weeks), chickens for fattening and turkeys for fattening (< 12 weeks)
0,03
Premixtures for use in feed in which the use of diclazuril is not authorised.
(3)
Feed additives not registered in the EU which are intended for use in feeds for export out-side the EU.
All feeds intended for marketing within the EU. 1
17 March 2010 GMP+ International
3.2 Additional information for some coccidiostats and histomonostats *
Trade name Manufacturer Importer Concentration Coefficient
Pigs OtherCompound of narasin and nicarbazine (E 772)Maxiban G 160 premix Eli Lilly Eli Lilly Nederland BV 80 g/kg narasin
80 g/kg nicarbazine5 1
Lasalocid sodium (E 763)Avatec 15% CC Roche Alpharma 15g/100g Lasalocide-sodium 1 1Robenidine-hydrochloride (E758)Cycostat 66G Roche Alpharma 66g/kg Robenidine-
hydrochloride1 1
Monensin-sodium (E757)Elancoban G200 premix Eli Lilly Eli Lilly Nederland BV 200g/kg monensin sodium 1 1Coxidin (5 1 701) Huvepharma Huvepharma NV 200g/kg monensin natrium 1 1Narasin (E765)Monteban G100 premix Eli Lilly Eli Lilly Nederland BV 100g/kg narasin 1 1Halofuginone-hydrobromine (764)Stenorol Huvepharma Huvepharma NV 6 g/kg halofuginone
hydrobromide1 1
Diclazuril (E 771)Clinacox 0,5 % Premix Janssen
Pharmaceutica nvJanssenPharmaceutica nv
0.5g/100g diclazuril 2 2
Salinomycin-sodium (E 766)Sacox 120 microGranulate Huvepharma Huvepharma NV 120g/kg salinomycine 1 1Other Other Other N/a 3 3
*: This list can be extended at new available data of relative wall adhesion test
Product standards 61/71
4 Residue standards for critical veterinary medical pro- ducts
4.1 Summary of residue standards for critical veterinary medical products
Veterinary medical product
Established maximum residue standards in animal feeds
4 in
ppm
Established precautionary measure for dairy cattle
laying hens
5slaughter
chickens6
fattening
turkeys6
pigs7
dairy cattle
8
Sulfadiazine sodium 5 8 1 1
Sulfamethoxazol 5 8 1 1
Doxycycline 8 8 10 -9 1 batch
10
Oxytetracycline 1 10 10 -9 1 batch
10
Ivermectine 0.1 0.1 0.1 -9 1 batch
10
Tiamuline 1 8 10 -9 1 charge
10
Tilmicosine 1 4 10 -9 1 charge
10
Trimethoprim Linked to Sulfadiazine and therefore sufficiently guaranteed
for export (not in NL for animal feed registered materials) and for any new registrations in the Netherlands
1 1 1 1
4The max. residue norms for premixes amount to maximum. 50% of the indicated residue norms for animal feeds calculated on an animal feed basis
5feed given to laying animals
6feed given from 5 days before slaughter
7feed given from 28 days before slaughter
8feed given to milk-producing cows, goats and sheep
9At this moment there is insufficient knowledge available in order to be able to establish a carry- over norm for this additive for these categories.
10 Dairy cow feed may not immediately be produced on a production line which has just produced
feed with these additives.
Product standards 62/71
17 March 2010 GMP+ International
4.2 Additional information per critical veterinary medical product
Trade name Registration holder Registration number Concentration Coefficient max dosing
Sulphadiazine sodium(trimethoprim)
Pigs Other
Feedmix Trim/sul 80/420 Aesculaap BV RegNL 1808 77 g/kg 5 3 385 ppm (5kg/t)
Trimethosulf premix Eurovet RegNL 7589 62.5 g/kg 5 2 312 ppm ( 5kg/t)625 ppm ( 10kg/t)
Feedmix sulfatrim Dopharma RegNL 8541 60 g/kg 5 3 480 ppm ( 8kg/t)600 ppm ( 10kg/t)
Sulphamethoxazol (trimethoprim)
Feedmix TS Dopharma RegNL 8674 50 g/kg 5 3 250 ppm (5kg/t)
500 ppm (10kg/t)
Bromine hexine hydrochloride/doxycyclinehyclate
Feedmix Doxy-B Dopharma RegNL 2588 20 g/kg 2,5 2,5 100 ppm (5kg/t)
300 ppm (15kg/t)
Pulmodox 5% Premix Virbac Laboratories RegNL 9826 50g/kg 2,5 2,5 250 ppm (5kg/t)
Doxyprex Industrial Veterinaria S. A. RegNL 10393 100g/kg 2,5 2,5 250 ppm (2,5kg/t)
Oxytetracycline
Feedmix V4 Dopharma RegNL 2158 80g/kg 3 3 400 ppm (5kg/t)
800 ppm (10kg/t)
Feedmix Oxy 10% Dopharma RegNL 2004 100g/kg 3 3 300 ppm (3kg/t)
700 ppm (7kg/t)
OTC-400 Framelco B.V. RegNL 7254 80g/kg 3 3 400 ppm (5kg/t)
OXY-400 V4 Eurovet RegNL 7277 80g/kg 3 3 400 ppm (5kg/t)
Product standards 63/71
17 March 2010 GMP+ International
Trade name Registration holder Registration number Concentration Coefficient max dosing
Ivermectine
Ivomec Premix Merial RegNL 8731 6/kg11
3 3 10 ppm12
Noromectin Premix 0,6% G/Gvoor varkens
Tiamulin
Norbrook LaboratoriesLtd
RegNL 10465 6g/kg11
3 3 10 ppm12
Tiamutin 10% premix Novartis RegNL 8015 100g/kg 3 3 30-40ppm
Denagard 2% premix Novartis RegNL 8016 20g/kg 3 3 30-40ppm
Tialin 10% premix Eurovet RegNL 10178 100g/kg 3 3 30-40ppm
Tialin 2% premix Eurovet RegNL 10177 20g/kg 3 3 30-40ppm
Vetmulin 2% premix Huvepharma N.V. RegNL 100731 20g/kg 3 3 175ppm
Vetmulin 10% premix for medicated feed
Tilmicosine
Huvepharma N.V. RegNL 101337 100g/kg 3 3 175ppm
Pulmotil G40 PREMIX Eli Lilly/Elanco Health RegNL 9166 40g/kg 3 3 tot 400 ppm
Pulmotil G100 PREMIX Eli Lilly/Elanco Health RegNL 9167 100g/kg 3 3 tot 400 ppm
Pulmotil G200 PREMIX Eli Lilly/Elanco Health RegNL 9168 200g/kg 3 3 tot 400 ppm
Pneumotil G40 PREMIX Eli Lilly/Elanco Health RegNL 10368 40g/kg 3 3 tot 400 ppm
Tilmovet 10%, premix for medicated feed for pigs
Huvepharma N.V. RegNL 100528 100g/kg 3 3 400 ppm
Tilmovet 4% Huvepharma N.V. RegNL 100739 40g/kg 3 3 400 ppm
Tilmovet 20%, premix for medicated feed for pigs
Huvepharma N.V. RegNL 100742 200g/kg 3 3 400 ppm
11 The product is made by mixing 0.33 kg premix (concentration 6 g/kg) in 5 kg premix.
12 Dosing for sow feed, calculated on the basis of dosing 100 microgrammes ivermectine per kg delivered weight.
Product standards 64/71
17 March 2010 GMP+ International
Trade name Registration holder Registration number Concentration Coefficient max dosing
for export (not in NL for animal feed registered materials) and for any new registrations in the Netherlands
Reg NL .... .... 3 3 ….
Product standards 65/71
17 March 2010 GMP+ International
Overview of admissible medicated premixes
Trade name Registration holder Registration Concentra- Coefficient Max. dosing fornummer tion complete feeds
Pigs OtherAmoxicillineSuramox 5% premix Virbac Nederland B.V. REG NL 8543 50g/kg 3 3 400 ppm (8kg/ton)
1
AmproliumhydrochlorideAmprolium Concentrate 25% Dopharma Research B.V. REG NL 2051 250g/kg - 3 500 ppm (2kg/ton)
2
Doxycyclinehyclaat/broomhexinehydrochlorideFeedmix Doxy-B Dopharma Research B.V. REG NL 2588 20g/kg 2,5 2,5 300 ppm (15kg/t)
3
Pulmodox 5% Premix Virbac Laboratories REG NL 9826 50g/kg 2,5 2,5 250 ppm (5kg/t)4
Doxyprex Industrial Veterinaria S. A. REG NL 100g/kg 2,5 2,5 250 ppm (2,5kg/t)5
10393FlorfenicolNuflor 40mg/g medicated Intervet Nederland B.V. REG NL 40g/kg 3 3 200 ppm (5kg/t)
6
premix for pigs 10473FlubendazolFeedmix Flubendazole Dopharma Research B.V. REG NL 9674 6g/kg 3 3 30 ppm (5kg/t) (pigs,
chickens)60 ppm (10kg/t)pheasants)
Flubenol 0.6% Janssen Pharmaceutica N.V. REG NL 5335 6g/kg 3 3 30 ppm (5kg/t) (pigs,chickens)60 ppm (10kg/t)(pheasants)
Flubenol 5% Janssen Pharmaceutica N.V. REG NL 3106 50g/kg 3 3 30 ppm (0,6kg/t) (pigs, chickens)
7
60 ppm (1,2kg/t) (pheasants)
7
Flubenol 5% Poultry Janssen Pharmaceutica N.V. REG NL 9556 50g/kg - 3 30 ppm (0,6kg/t) (chickens)
7
60 ppm (1,2kg/t) (pheasants)
7
Flubenol 50% Janssen Pharmaceutica N.V. REG NL 3160 500g/kg 3 3 30 ppm (0,06kg/t) (pigs, chickens)
8
60 ppm (0,12kg/t)
Product standards 66/71
17 March 2010 GMP+ International
Trade name Registration holder Registration nummer
Concentra- tion
Coefficient Max. dosing for complete feeds
Pigs Other(pheasants)
8
Flubenol 7.5% Janssen Pharmaceutica N.V. REG NL 5261 75g/kg 3 3 30 ppm (0,4kg/t) (pigs, chickens)
9
60 ppm (0,8kg/t) (pheasants)
9
Flutelmium 0.6% Janssen Pharmaceutica N.V. REG NL 6082 6g/kg 3 3 30 ppm (5kg/t) (pigs, chickens)60 ppm (10kg/t) (pheasants)
Flutelmium 7,5% Janssen Pharmaceutica N.V. REG NL 6010 75g/kg 3 3 30 ppm (0,4kg/t) (pigs, chickens)
9
60 ppm (0,8kg/t) (pheasants)
9
Flubenol 5% Wirtz Farma B.V. REG NL10380/3106
Flubenol 5% Schippers Bladel B.V. REG NL10451/3106
Flubendazol 5% concentrate Dopharma Research B.V. REG NL101512
Ivermectine
50 g/kg 3 3 30 ppm (0,6kg/t) (pigs, chickens)
7
60 ppm (1,2kg/t) (pheasants)
7
50 g/kg 3 3 30 ppm (0,6kg/t) (pigs, chickens)
7
60 ppm (1,2kg/t) (pheasants)
7
50g/kg 3 3 30 ppm (0,6kg/t) (pigs, chickens)
7
60 ppm (1,2kg/t) (pheasants)
7
Ivomec Premix Merial B.V. REG NL 8731 6g/kg 3 3 2,4 ppm (0,4kg/t)10
Noromectin Premix 0,6% G/G for pigs
Norbrook Laboratories Ltd(Station Works)
REG NL10465
6g/kg 3 3 2,4 ppm (0,4kg/t)10
Ecomectin 6mg/g premix ECO Animal Health LTD. REG NL10529
6g/kg 3 3 2,4 ppm (0,4kg/t)10
Lincomycine(-hydrochloride)/Spectinomycine(-sulfaat)Lincomix 110 Pfizer Animal Health B.V. REG NL 7957 110g/kg Linco 3 3 220 ppm (2,0kg/t)
11
Product standards 67/71
17 March 2010 GMP+ International
Trade name Registration holder Registration nummer
Concentra- tion
Coefficient Max. dosing for complete feeds
Pigs OtherLincomix 220 premix Pfizer Animal Health B.V. REG NL
1007644g/kg Linco. 3 3 220 ppm (5kg/t)
Vualin Plus-33 V11 Eurovet Animal Health B.V. REG NL 2295 6,6g/kg Linco.6,6g/kg Spec
Feedmix V11 Dopharma Research B.V. REG NL 5068 6,6g/kg Linco.6,6g/kg Spec
Linco-spectin Premix Pfizer Animal Health B.V. REG NL 9708 22g/kg Linco.22g/kg Spec
3 3 33 ppm (5kg/t)
3 3 33 ppm (5kg/t)
3 3 44 ppm (2kg/t)12
Oxytetracycline(-hydrochloride)
Feedmix V4 Dopharma Research B.V. REG NL 2158 80g/kg 3 3 800 ppm (10kg/t) Feedmix Oxy 10% Dopharma Research B.V. REG NL 2004 100g/kg 3 3 700 ppm ( 7kg/t) OTC-400 Framelco B.V. REG NL 7254 80g/kg 3 3 400 ppm (5kg/t)OXY-400 V4 Eurovet Animal Health B.V. REG NL 7277 80g/kg 3 3 1000 ppm (12,5kg/t)ParacetamolPracetam 10% Laboratoires Sogeval REG NL
10278100g/kg 3 3 800 ppm (8kg/t)
Sulfadiazinenatrium/TrimethoprimFeedmix Trim/sul 80/420 Aesculaap BV REG NL 1808 77,1g/kg Sulfa 5 3 385 ppm Sulfa en
16g/kg Trim 80 ppm Trim (5kg/t)Trimethosulf premix Eurovet Animal Health B.V. REG NL 7589 62,5g/kg Sulfa 5 2 625 ppm Sulfa en
12,5g/kg Trim 125 ppm Trim (10kg/t)Feedmix sulfatrim Dopharma Research B.V. REG NL 8541 60g/kg Sulfa 5 3 600 ppm Sulfa en 120
12g/kg Trim ppm Trim (10kg/t)Sulfamethoxazol/TrimethoprimFeedmix TS Dopharma Research B.V. REG NL 8674 50g/kg Sulfa 5 3 500 ppm Sulfa en
10g/kg Trim 100 ppm Trim (10kg/t)TiamulinwaterstoffumaraatTiamutin 10% premix Novartis Consumer Health B.V. REG NL 8015 100g/kg 3 3 40 ppm (0,4 kg/t)
13
Denagard 2% premix Novartis Consumer Health B.V. REG NL 8016 20g/kg 3 3 40 ppm (2,4 kg/t)14
Tialin 10% premix Eurovet Animal Health B.V. REG NL 100g/kg 3 3 40 ppm (0,4 kg/t)13
Tialin 2% premix Eurovet Animal Health B.V.10178REG NL 20g/kg 3 3 40 ppm (2,4 kg/t)
14
10177Vetmulin 2% premix Huvepharma N.V. REG NL 20g/kg 3 3 176 ppm (8,8 kg/t)
Product standards 68/71
17 March 2010 GMP+ International
Trade name Registration holder Registration nummer
100731
Concentra- tion
Coefficient Max. dosing for complete feeds
Pigs Other
Vetmulin 10% premix for medicated feeds Tilmicosinefosfaat
Huvepharma N.V. REG NL101337
100g/kg 3 3 180 ppm (1,8 kg/t)
Pulmotil G40 PREMIX Eli Lilly Nederland B.V /ElancoAnimal Health
Pulmotil G100 PREMIX Eli Lilly Nederland B.V /ElancoAnimal Health
Pulmotil G200 PREMIX Eli Lilly Nederland B.V /ElancoAnimal Health
REG NL 9166 40g/kg 3 3 400 ppm (10 kg/t) (pigs)200 ppm (5 kg/t) (rabbits)
REG NL 9167 100g/kg 3 3 400 ppm (4 kg/t) (pigs)200 ppm (2 kg/t) (rabbits)
REG NL 9168 200g/kg 3 3 400 ppm (2 kg/t) (pigs)200 ppm (1 kg/t) (rabbits)
Pneumotil G40 PREMIX Eli Lilly Nederland B.V /ElancoAnimal Health
REG NL10368
40g/kg 3 3 400 ppm (10 kg/t)
Tilmovet 10%, premix for medicated feed for pigs
Huvepharma N.V. REG NL100528
100g/kg 3 3 400 ppm (4 kg/t)
Tilmovet 4% Huvepharma N.V. REG NL100739
40g/kg 3 3 400 ppm (10 kg/t)
Tilmovet 20%, premix for medicated feeds for pigs
Huvepharma N.V. REG NL100742
200g/kg 3 3 400 ppm (2 kg/t)
TylosinefosfaatTylan 100 Premix 10% Eli Lilly Nederland B.V /Elanco
Animal Health
Tylan 20 premix 2% Eli Lilly Nederland B.V /ElancoAnimal Health
REG NL 3917 100g/kg 3 3 200 ppm (2 kg/t) (pigs)1100 ppm (11 kg/t) (, chickens reared for laying)
REG NL 9976 20g/kg 3 3 200 ppm (10 kg/t) (pigs)1100 ppm (55 kg/t)
Product standards 69/71
17 March 2010 GMP+ International
Trade name Registration holder Registration nummer
Concentra- tion
Coefficient Max. dosing for complete feeds
Pigs Other
Tylan G250 Premix 25% Eli Lilly Nederland B.V /ElancoAnimal Health
(slaughter chickens, chickens reared for laying)
REG NL 9982 250g/kg 3 3 200 ppm (0.8 kg/t)15
(pigs)1100 ppm (4,4 kg/t)
15
(slaughter chickens, chickens reared for laying)
Pharmasin 100mg/g premix for medicated feeds for pigs, slaughter chickens and chickens reared for laying
Pharmasin 250mg/g premix for medicated feeds pigs, slaughter chickens and chickens reared for laying
Huvepharma N.V. REG NL101024
Huvepharma N.V. REG NL101027
100g/kg 3 3 200 ppm (2 kg/t) 13
(pigs)1100 ppm (11 kg/t) (slaughter chickens, chickens reared for laying)
250g/kg 3 3 200 ppm (0.8 kg/t)15
(pigs, chickens)1100 ppm (4,4 kg/t)
15
(slaughter chickens, chickens reared for laying)
for export (not in NL for animal feed registered materials) and for any new registrations in the Netherlands
- - .... 3 3 ….
Product standards 70/71
17 March 2010 GMP+ International
1: Dosage for weaned piglets, calculated on the basis of a 15 mg dose of amoxicillin per kg of body weight per day.2: The product is made up by mixing 2 kg of premix (concentration 250 g / kg) to 5 kg premix.
3: The dose was calculated on the basis of a 10 mg dose of doxycycline and 1 mg dose of bromine hexine per kg of body weight per day.
4: The dose was calculated on the basis of a 12.5 mg dose of doxycycline per kg of body weight per day.
5: The dose was calculated on the basis of a 10 mg dose of doxycycline per kg of body weight per day.
6: The dose was calculated on the basis of a 10 mg dose of florfenicol per kg of body weight per day.
7: The product is made up by mixing XX kg of premix (concentration 50 g/ kg) to 5 kg premix.
8: The product is made up by mixing XX kg of premix (concentration 500 g / kg) to 5 kg premix.
9: The product is made up by mixing XX kg of premix (concentration 75 g / kg) to 5 kg premix.
10: The dose was calculated on the basis of a 0,1 mg dose of ivermectine per kg of body weight per day.
11: The product is made up by mixing XX kg of premix (concentration 110 g / kg) to 5 kg premix.
12: The product is made up by mixing XX kg of premix (concentration 22 g / kg) to 5 kg premix.
13: The product is made up by mixing XX kg of premix (concentration 100 g / kg) to 5 kg premix.
14: The product is made up by mixing XX kg of premix (concentration 20 g / kg) to 5 kg premix.
15: The product is made up by mixing XX kg of premix (concentration 250 g / kg) to 5 kg premix.
Product standards 71/71
17 March 2010 GMP+ International